• Revagenix initiates Phase 1 trial of Rev-56 inhaled antibiotic for NCFB

  US-based biopharm Revagenix announced that it has initiated a Phase 1 trial of Rev-56, which it describes as an “inhaled, anti-pseudomonal therapy for non-cystic fibrosis bronchiectasis (NCFB).” The first part of the study will evaluate… [Read more . . .]

• FDA approves Cipla’s ANDA for a generic of Advair Diskus fluticasone / salmeterol DPI

  According to Cipla, the FDA has approved the company’s ANDA for 100/50 mcg, 250/50 mcg, and 500/50 mcg strengths of its generic version of Advair Diskus fluticasone propionate / salmeterol DPI for the treatment of… [Read more . . .]

• CHMP adopts negative opinion regarding Cessatech and Proveca’s KemSu (CT001) sufentanil / ketamine nasal spray for pediatric patients

  According to Cessatech, the EMA’s Committee for Medicinal Products for Human Use has adopted a negative opinion regarding Proveca’s  pediatric-use marketing authorization (PUMA) of KemSu (CT001) sufentanil / ketamine nasal spray for the treatment of… [Read more . . .]

• Nanopharm facility in Wales gets GMP certification

  According to Aptar Pharma, parent company of OINDP-focused CRO Nanopharm, the UK Medicines and Healthcare Products Regulatory Agency has completed an inspection of Nanopharm’s facility in Cwmbran, Wales and has certified the location as GMP compliant.… [Read more . . .]

• HFO 1234ze formulation of AstraZeneca’s Breztri Aerosphere budesonide / glycopyrronium / formoterol MDI approved in Australia

  According to AstraZeneca, the Australian Therapeutic Goods Administration has approved a reformulated Breztri (Trixeo) Aerosphere budesonide / glycopyrronium / formoterol fumarate MDI with Solstice‘s Solstice Air HFO-1234ze as the propellant. Breztri is approved in Australia for the treatment of… [Read more . . .]

• MHRA approves HFA 152a formulation of Chiesi’s Clenil Modulite beclametasone MDI

• FDA approves pediatric use of Glenmark’s Ryaltris olopatadine / mometasone nasal spray for seasonal allergic rhinitis

• Eli Lilly to acquire AtaiBeckley and its BPL-003 intranasal mebufotenin

• SHS Capital acquires majority stake in Basic Pharma

• VaxDome partners with Matica Bio on development of intranasal antiviral / vaccine

More news . . .